Metastatic uveal melanoma MedDRA version: 21.1 Level: PT Classification code 10081431 Term: Uveal melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Yervoy
Pharmaceutical Form: Infusion
INN or Proposed INN: IPILIMUMAB
CAS Number: 477202-00-9
Current Sponsor code: BMS-734016
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is =18 years of age on the day of signing informed consent 2. Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures 3. Patient must have a histologically confirmed diagnosis of stage IV uveal melanoma. If tissue biopsy is judged not feasible by the investigator, cytological diagnosis from fine needle aspiration (FNA) will be accepted 4. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria with at least one target lesion identified in the liver. 5. ECOG performance status of 0 or 1 6. No previous immunotherapy for uveal melanoma metastases. 7. Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required 8. Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject 9. Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 3 months 2. Body mass index above 35 3. More than 50% of the liver volume replaced by tumor as measured by CT or MRI 4. Known congestive heart failure with an LVEF =1.5xULN or Creatinine Clearance 3*ULN and PK-INR>1.5) or medical history of liver cirrhosis or portal hypertension 9. Hemoglobin 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 15. Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs 16. Has a known additional malignancy that is progressing or requires active treatment. 17. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug. 18. A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and tolerability of isolated hepatic perfusion (IHP) together with ipilimumab and nivolumab;Secondary Objective: The secondary objective is to evaluate efficacy of the combined treatment with IHP, ipilimumab and nivolumab.;Primary end point(s): •Incidence and severity of adverse events (AEs) and serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluation of objective response rate (ORR) • Evaluation of clinical benefit rate (CBR) • Evaluation of progression-free survival (PFS) • Evaluation of hepatic progression-free survival (hPFS) • Evaluation of overall survival (OS) • Evaluation of time to response (TTR) • Evaluation of duration of response (DOR);Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Sweden
Contacts
Public ContactGothia Forum
Sahlgrenska University Hospital
Outcome results
None listed